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Paxil Birth Defect Lawsuit Set to Start in Philadelphia

  • Written by: AboutLawsuits
  • 5 Comments

The first Paxil lawsuit against GlaxoSmithKline over alleged birth defects caused by their antidepressant, is scheduled for trial to begin today in Philadelphia, in what is the first of about 600 similar claims involving heart defects and other injuries suffered by babies born to women who used Paxil.

The lawsuit, brought by plaintiff Michelle David, claims that her use of Paxil resulted in life-threatening heart defects in her three-year-old son, Lyam Kilker. The case is the first of three early trials that are likely to set the tone of plaintiff and defense strategies, and potentially create the basis for a future resolution of the Paxil birth defect lawsuits.

Paxil, known generically as paroxetine, is a selective serotonin reuptake inhibitor prescribed to treat depression. It was originally approved in 1992, and has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

Plaintiffs claim that GlaxoSmithKline knew about the potential for Paxil to cause birth defects, but hid data and failed to warn users of the potential birth defect side effects. The FDA released an alert on December 8, 2005, that studies showed the drug could increase the risk of heart defects in infants when taken during the first three months of pregnancy. The agency also required the company to update Paxil label warnings to include the risk of birth defects.

GlaxoSmithKline has already settled several claims involving the antidepressant, including a $40 million settlement of a Paxil class action lawsuit brought by health insurers who claimed that the company withheld information that the antidepressant was much less effective on children and teens. The company also settled a lawsuit claiming it withheld safety information on increased suicide risks associated with Paxil brought by the New York Attorney General’s office.

GlaxoSmithKline officials say there is no conclusive evidence that Paxil causes birth defects, and intend to argue that the injury suffered by the plaintiff’s son was not caused by the use of Paxil. David’s son was born with holes in his heart that had to be addressed with multiple surgeries before he was six months old, which the lawsuit says is the result of her use of Paxil. David maintains that she would not have taken the drug if she had known of the potential risk to her then unborn child.

Plaintiff lawyers contend that the company knew of the potential risks years before the drug was approved, and allege they withheld and destroyed test data that indicated there was an increased risk of Paxil birth defects. Similar claims were made in the New York settlement regarding Paxil suicide risks.

Paxil settlement agreements forced the company to release a large amount of previously undisclosed test trial data on other drugs as well, which has led to findings of other side effects. An independent meta-analysis of data released involving clinical trials for GlaxoSmithKline’s diabetes drug Avandia was published in the New England Journal of Medicine in May 2007, leading to the discovery that Avandia side effects may increase the risk of heart attacks and death.

In March of this year, GlaxoSmithKline announced that it was changing company policies to ensure that all drug research data was released within 18 months of completion.

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5 comments

  1. Kelly Reply

    I was taking paxil before, during and after my pregnancy in 2003. My son was born with a rare heart defect and passed away at one month old. Had I KNOWN about the risk of paxil, I wouldn’t have even considered it. At all.

    I am part of the 600+ cases awaiting trial.

  2. Heather Reply

    I was put on paxil when i found out i was pregnant.The md assured me it was safe. My son was born with traumatic cold body temps and heart murmurr.He would not open his eyes and was lethargic for 8 weeks in/out of hospitols….He now has left heart valve insuffiecencies, asthma, aspergers and sees many specialits.I heard about this claim when my son was 4.I am one of the 600 plus…..

  3. jessica Reply

    i took paxil my first trimester, if i would have known what this drug was going to do i would have NEVER taken it. i was told it was safe. my son died at 17 months old from heart and lung defects caused by paxil. i am one of the 600 + cases waiting.

  4. Regina Reply

    I took Paxil for a long time. Fortunately, neither of my children died; however, my oldest child has mitrovalve prolapse, and my younger child has a heart murmur. We recently discovered the oldest child could have died at any given moment and we were unaware! What finally brought the heart defect to light was the beginning of her having seizures and blacking out.
    My younger daughter has dizzy spells caused from her heart not beating as it should, although she has been healthy for the most part.

  5. Amanda Reply

    I took paxil in my first trimester,HAD I KNOWN MY SON WOULD SUFFER EVRYDAY FOR THE REST OF HIS LIFE,I WOULD HAVE NEVER USED THIS MEDICATION,my son was born with a rare heart condition called Hypo Plastic Left Heart Syndrome,He has had too open heart surgerys 1 ay birth,1 at 6 months,an was due for a 3rd at 2 yrs of age,however almost to the 2 yr. old stage his heart gotten weeker,has had strokes, an now my son is on a donor list,uses multiple medications several times a day,an endless doctors apps. It is a constant struggle for me as his mother but my pain is NOTHING compared to his.And I think it is so sicking what ths company has done,knowing about the risks an hiding it?WHO THE HELL DO U THINK U R?playing god with unborn children,u r heartless,heartless ppl,Iam also a part of the 600+ awaiting trail,BUT NO MATTER THE OUTCOME, NO $ AMOUNT WILL EVER MAKE THIS RIGHT FOR MY SON, OR THE REST WHO LOST LOVED ONES EITHER,AFTER ALL THERE IS NO PRICE TAG ON S/O ‘S LIFE ESP. NOT A CHILD

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